FDA says Astellas has recalled one lot each of its Prograf and Astagraf transplant medications that may contain empty capsules.
FDA warns Greeces Rontis Hellas about Quality System and Medical Device Reporting violations in its production of a balloon catheter.
FDA approves Bristol Myers Squibbs Opdivo Qvantig subcutaneous injection for several cancer indications.
FDA approves Checkpoint Therapeutics Unloxcyt to treat some squamous cell cancer patients.
FDA warns Indias Bhargava Phytolab about CGMP issues in its manufacturing of finished drugs and active pharmaceutical ingredients.
FDA recommends that companies making transmucosal buprenorphine drugs indicated to treat opioid dependence revise the labeling to indicate there is no...
FDA approves Neurocrine Biosciences Crenessity to be used with glucocorticoids to control androgen in adult and some pediatric patients with classic c...
FDA says Endo USA has recalled its Adrenalin Chloride Solution that predates the Federal Food, Drug, and Cosmetic Act and was never submitted for FDA ...